Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening (KCCQ-WHF)

Patient-Reported Health Status Assessment Using the Kansas City Cardiomyopathy Questionnaire for Early Detection of Heart Failure Worsening

This observational feasibility study aims to assess (i) how practical and acceptable repeated KCCQ assessments are; (ii) the connection between changes over time in KCCQ scores and signs of congestion; and (iii) clinical outcomes, including worsening heart failure events or cardiovascular death (CVD), and the time between 5- and 10-point KCCQ changes and clinical events.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Serial KCCQ assessments delivered via chatbot

Detailed Description

The course of heart failure (HF) is characterized by episodes of worsening HF (WHF). These episodes increase the risk of hospitalization and death. Currently, reliable instruments for early identification of WHF are underdeveloped. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific, self-administered instrument designed to assess patient status. KCCQ allows detection of changes in clinical status in HF patients within a 14-day recall period and has the potential for early detection of WHF.

The study is an investigator-initiated, prospective, observational feasibility study aims to assess the (i) feasibility and acceptability of serial KCCQ assessment; (ii) the relationship between temporal changes in KCCQ scores and markers of congestion, as well as (iii) clinical outcome, a composite of worsening heart failure events or cardiovascular death (CVD), and the time from 5- and 10-point KCCQ changes to clinical events.

The study population will include 120 patients aged 18 years and above who meet the criteria. Eligible patients will undergo serial KCCQ assessments every 2 weeks for 12 months. Transthoracic echocardiography (TTE), lung ultrasound (LUS), 6-minute walk test (6MWT), and blood sampling will be performed at baseline, 3, 6, and 12 months. Outcomes will be collected at 6 and 12 months.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Anastasia Shchendrygina; Phone Number: +79262309207; Email: a.shchendrygina@gmail.com
• Study Contact Backup: Name: Svetlana Rachina; Email: rachina_s_a@staff.sechenov.ru

Study Locations

• Russia
  • Non-US/Non-Canadian
    • Moscow, Non-US/Non-Canadian, Russia
      • Recruiting
      • I.M. Sechenov First Moscow State Medical University (Sechenov University)
      • Contact: Anastasia Shchendrygina; Phone Number: +79262309207; Email: a.shchendrygina@gmail.com
      • Contact: Svetlana Rachina; Email: rachina_s_a@staff.sechenov.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Men and women aged ≥ 18 years with an established diagnosis of heart falure who were admitted to the center the last 6 months will be candidates for screening. They will be enrolled if they meet the inclusion criteria and none of the exclusion criteria are present. If hospitalized at the time of screening, the patient will be enrolled in the study after stabilization and when free of signs and symptoms of congestion (defined as jugular venous pressure of <8 cm, with no pulmonary rales, orthopnea, and with trace peripheral edema or no edema) and is stable on a maintenance dose of oral diuretics for 48 hours.

Description

Inclusion Criteria:

• Established diagnosis of chronic HF with reduced, mildly reduced, or preserved ejection fraction, NYHA II-III
• History of heart failure (HF) hospitalization within the last 6 months before enrollment, defined as the presence of dyspnea, elevated NT-proBNP ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF), and 2 of the following: i. Rales on chest auscultation or signs of congestion on X-ray/CT scan; ii. Peripheral Oedema; iii. Loop diuretics IV at admission
• Free of signs and symptoms of congestion, defined as JVP of <8 cm, with no orthopnea, pulmonary rales, and with trace peripheral edema or no edema.
• Stable doses of oral loop diuretics, if prescribed
• Ability to provide informed consent

Exclusion Criteria:

• Acute coronary syndrome, cardiac surgery, pulmonary embolism, cerebrovascular accident, ablation of atrial flutter/fibrillation, valve repair/replacement, implanted cardioverter defibrillator or urgent PCI within the last 3 months
• Planned interventions, including major cardiac surgery (coronary artery bypass grafting, valve repair/replacement, ventricular assist device, cardiac transplantation), coronary revascularization, implantation of a cardiac device or ablation of atrial flutter/fibrillation during the study
• Previous cardiac transplantation and candidates for heart transplantation
• Complex congenital heart disease
• Heart failure due to active myocarditis, pericardial constriction, known hypertrophic cardiomyopathy or cardiac amyloidosis, or uncorrected severe valvular heart disease
• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
• Cirrhosis, chronic active hepatitis, or other severe hepatic disease
• Significant drug or alcohol abuse during the last year
• Hemodialysis
• Infective endocarditis
• Any active cancer

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with heart failure who have been hospitalized for heart failure within the past six months	Other: Serial KCCQ assessments delivered via chatbot; Eligible patients will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 14-day intervals for a duration of 12 months. The KCCQ will be assessed using a chatbot delivered via Telegram Messenger, developed specifically for this study by the research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible patients who consent and enrol in the study	Recruitment rate	6 and 12 months
Median time to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) delivered via chatbot		Baseline assesment
Proportion of those who stop the study	Dropout rate	6 and 12 months
Proportion of completed KCCQ relative to those scheduled	Adherence to the protocol	6 and 12 months
The mean rank of patient satisfaction with the intervention assessed by a survey	Acceptability	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The regression coefficient (β) relating the change in KCCQ-Total Symptoms Score (KCCQ-TSS) to the change in early mitral inflow velocity to early diastolic mitral annular velocity (E/e' ratio) assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in left atrial volume index (LAVI) assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in tricuspid regurgitation (TR) velocity assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in pulmonary capillary wedge pressure (PCWP) assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in inferior vena cava (IVC) assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in total number of B-lines assessed by lung ultrasound at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS and changes in N-terminal pro-B-type Natriuretic Peptide (NTproBNP) at 3,6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS and changes in Cancer Antigen 125 (CA-125) at 3,6 and 12 months.	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in the 6-Minute Walk (6MW) distance	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ Clinical Summary Score (KCCQ-CSS) to the change in E/e' ratio assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-CSS to the change in LAVI assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-CSS to the change in TR velocity assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-CSS to the change in PCWP assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS to the change in inferior vena cava IVC assessed by echocardiography at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS to the change in total number of B-lines assessed by lung ultrasound at 3, 6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS and changes in NTproBNP at 3,6 and 12 months	3, 6 and 12 months
The regression coefficient (β) relating changes in KCCQ-СSS to changes in CA-125 at 3, 6, and 12 months.	3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS to the change in the 6-MW distance	3, 6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal changes in KCCQ-TSS to a composite of worsening heart failure (WHF) events and their components	Composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death.	6 and 12 months
Temporal changes in KCCQ-OSS, KCCQ-CSS, and PLS to a composite of WHF events and their components	A composite of WHF events to composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death.	6 and 12 months
Mean time from 5- and 10-point change in KCCQ-TSS to a composite WHF events	Composite of WHF events to composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death	6 and 12 months
Mean time from 5- and 10-point change KCCQ-OSS, KCCQ-CSS, and PLS to a composite of WHF events	A composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death/.	6 and 12 months

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Anastasia Shchendrygina, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Heart failure; Heart Diseases; Congestion; Kansas City Cardiomyopathy Questionnaire; monitoring; worsening heart failure
• Additional Relevant MeSH Terms: Heart Failure; Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 10-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No